Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease



Status:Completed
Conditions:Alzheimer Disease, Neurology, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:50 - 95
Updated:4/21/2016
Start Date:November 2012
End Date:May 2015

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A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Efficacy and Safety Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheimer's Disease

The primary purpose of this study is to determine whether ELND005 is effective in treating
symptoms of agitation and aggression in patients with Alzheimer's disease


Inclusion Criteria:

- Diagnosis of Probable AD according to the National Institute on Aging- Alzheimer's
Association (NIA-AA) guidelines (McKhann et al 2011).

- MMSE score of 5 to 24 (inclusive) at the Screening Visit.

- Has clinically significant agitation/aggression defined as Neuropsychiatric Inventory
(NPI)-agitation/aggression subscore of ≥4.

- No response or suboptimal response to standard nonpharmacological interventions.

Exclusion Criteria:

- The agitation/aggression is attributable to concomitant medications, environmental
conditions, or active medical or psychiatric condition.

- Current diagnosis of major depressive disorder according to the criteria of the
Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision
(DSM IV TR).

- Has persistent and distressing psychotic symptoms (delusion and/or hallucinations)
that require psychiatric hospitalization.
We found this trial at
58
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Irvine, California 92697
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Abington, Pennsylvania 19001
2377
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Ann Arbor, Michigan 48105
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Atlantis, Florida 33462
2305
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2685
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Bangor, ME
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Bellevue, Washington 98007
959
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Birmingham, Alabama 35294
1785
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1189
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Calgary,
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Charlotte, North Carolina 28209
2101
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Charlotte, North Carolina 28209
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Columbus, Georgia 31909
1905
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Deerfield Beach, Florida 33064
2313
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Delray Beach, Florida 33445
2308
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1223
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DeSoto, TX
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Durham, North Carolina 27710
2201
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Easton, Maryland 21601
2333
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Encino, California 91316
28
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Escondido, California 92025
84
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Escondido, CA
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Fresno, California 93710
209
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Hattiesburg, Mississippi 39401
1675
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Jenkintown, Pennsylvania 19046
2376
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Lake Worth, Florida 33449
2297
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Long Beach, California 90806
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Los Alamitos, California 90720
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Los Angeles, California 90073
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Miami, Florida 33137
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Nashville, Tennessee 37212
1762
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Newport Beach, California 92663
33
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Norristown, Pennsylvania 19401
2365
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North Charleston, South Carolina 29406
2176
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Norwalk, Connecticut 06851
2462
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Oakland Park, Florida 33334
2314
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Oklahoma City, Oklahoma 73112
1165
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Orlando, Florida 32806
2186
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Ormond Beach, Florida 32174
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Paw Paw, Michigan 49079
1821
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Philadelphia, Pennsylvania 19104
2375
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Philadelphia, Pennsylvania 19104
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Phoenix, Arizona 85006
344
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Phoenix, Arizona 85006
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Pittsburgh, Pennsylvania 15213
2119
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Port Charlotte, Florida 33952
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Port Royal, South Carolina 29935
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Portland, Oregon 97225
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Richmond, Virginia 23230
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Rochester, New York 14623
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Rochester, New York 14623
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Santa Ana, California 92701
78
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Sarasota, Florida 34243
2145
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Savannah, Georgia 31419
2128
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Springfield, Illinois 62702
1610
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St. Paul, Minnesota 55130
1518
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Stratford, New Jersey 08084
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Sunrise, Florida 33351
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Washington, District of Columbia 20057
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Wilmington, North Carolina 28401
2275
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Winchester, Massachusetts 01890
2574
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Winston-Salem, North Carolina 27103
2122
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